UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009026
Receipt number R000010572
Scientific Title A phase II clinical study of 5-FU and sorafenib combination therapy in patients with hepatocellular carcinoma. Uncontrolled exploratory clinical study
Date of disclosure of the study information 2012/10/15
Last modified on 2012/10/02 19:56:36

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Basic information

Public title

A phase II clinical study of 5-FU and sorafenib combination therapy in patients with hepatocellular carcinoma.
Uncontrolled exploratory clinical study

Acronym

A phase II clinical study of 5-FU and sorafenib combination therapy in patients with hepatocellular carcinoma.
Uncontrolled exploratory clinical study

Scientific Title

A phase II clinical study of 5-FU and sorafenib combination therapy in patients with hepatocellular carcinoma.
Uncontrolled exploratory clinical study

Scientific Title:Acronym

A phase II clinical study of 5-FU and sorafenib combination therapy in patients with hepatocellular carcinoma.
Uncontrolled exploratory clinical study

Region

Japan


Condition

Condition

Hepatocellular carcinoma

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

This study is designed to assess the efficasy and safety of combination therapy with continuous systemic 5-fluorouracil(5-FU) infusion and Sorafenib in patients with hepatocellular carcinoma(HCC) unresectable for locoregional therapy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

One-year survival

Key secondary outcomes

OS
TTP
RR/DCR
Safety


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

The combination therapy of continuous intravenous infusion of 5-FU and sorafenib

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1)At least 20 years old when consent is given
2)Histologically or clinically (imaging and tumor markers) diagnosed hepatocellular carcinoma found to be ineligible for resection or local treatment
3)Lesions measurable with contrast-enhanced CT or contrast-enhanced MRI
4)Child-Pugh class A
5)ECOG performance status (PS) of 0 or 1
6)Major organs functional, satisfying the following: In tests performed 14 or fewer days before enrollment:
Neutrophil count >=1500/microL
Platelet count >=50000/microL
Hemoglobin >= 8.5 g/dL
Total bilirubin < 2.0 mg/dL
Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) <= 5 times the upper limit of the study center standard range
Serum creatinine (Cr) <=1.5 times the upper limit of the study center standard range
7)Capable of complying with requirements about visit days, medication, and laboratory tests
8)The patient has been fully informed and has an adequate understanding about the study and has given voluntary written consent before participation

Key exclusion criteria

1)History of use of Sorafenib or another molecular targeted drug
2)History of systemic chemotherapy
3)Clinically significant ascites (refractory ascites requiring drainage)
4)History of liver transplantation
5)Esophageal varices with the potential to bleed
6) Any of the following 12 or fewer months before enrollment in this research:
Myocardial infarction, unstable angina, cardiac failure, cerebrovascular disorder
7)Concurrent or prior hepatic encephalopathy
8)Brain tumor
9)On dialysis
10)Gastrointestinal hemorrhage during past month
11)Active multiple cancer
12)On a CYP3A4 inducer (rifampicin, phenobarbital, phenytoin, carbamazepine, dexamethasone) or food including St. John's wort.
13) Any of the following concurrent diseases:
Grade 2 or greater arrhythmia or poorly controlled hypertension according to the JCOG/JSCO Japanese translation of the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE v 4.0)
14)Contraindicated for any of the study drugs
15)Orally taking an herbal medicine approved for the treatment of cancer (e.g., shosaikoto)
16)Human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) related disease
17) Otherwise found ineligible as a subject by the researcher

Target sample size

98


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Makoto Chuma

Organization

Hokkaido University Hospital

Division name

Department of Gastroenterogy and Hematorogy

Zip code


Address

kita 14,Nishi 5,Kita-ku, Sapporo, Japan

TEL

011-716-1161(5920)

Email



Public contact

Name of contact person

1st name
Middle name
Last name Makoto Chuma

Organization

Hokkaido University Hospital

Division name

Department of Gastroenterogy and Hematorogy

Zip code


Address

kita 14,Nishi 5,Kita-ku, Sapporo, Japan

TEL

011-716-1161(5920)

Homepage URL


Email



Sponsor or person

Institute

Hokkaido University Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2012 Year 10 Month 15 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Open public recruiting

Date of protocol fixation

2012 Year 08 Month 29 Day

Date of IRB


Anticipated trial start date

2012 Year 09 Month 18 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 10 Month 02 Day

Last modified on

2012 Year 10 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010572


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name